A Study of HH-120 Nasal Spray in Close Contacts of Those Diagnosed With COVID-19

COVID-19 Clinical Trial

Official title:

A Single-Arm Clinical Study Evaluating the Efficacy of Post-Exposure Prophylaxis , Safety, and Tolerability of HH-120 Nasal Spray in Close Contacts of SARS-CoV-2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05747677
• Other study ID #: HH120-IIT-NS01
• Status: Completed
• Phase: N/A
• Start date: June 14, 2022
• Est. completion date: February 6, 2023

Study information

• Verified date: February 2023
• Source: Beijing Ditan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate the efficacy of post-exposure prevention and safety of HH-120 nasal spray in participants who are caregivers of hospitalized patients infected with SARS-CoV-2. HH-120 nasal spray are administrated 8-10 times to the participants per day until the discharge of the SARS-CoV-2 infected patients or confirmed infection of the participant, whichever occurs first.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 6, 2023
• Est. primary completion date: February 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female subjects aged 18 or above;

• Caregivers of hospitalized children who are infected with SARS-CoV-2;

• Negative qRT-PCR nucleic acid test result during the screening;

• Willing and able to give written informed consent.

Exclusion Criteria:

• Those who have child-bearing plan or are unable to voluntarily take effective contraceptive measures, or plan to donate sperm/ovum during the study or within 3 months after the end of the study;

• Female subjects who are positive for human chorionic gonadotropin (ß-Human Chorionic Gonadotropin, ß-HCG) or are breastfeeding;

• Have used antiviral drugs with a therapeutic effect on COVID-19 within 3 months before screening, including various monoclonal antibodies (tixagevimab and cilgavimab, tocilizumab, ambavirumab and romisvir, Bamlanivimab, Etesevimab, Bebtelovimab, Casirivimab and imdevimab, Sotrovimab), convalescent plasma, hydroxychloroquine, Paxlovid (Nimatevir/ritonavir), Azvudine, Baricitinib, molnupiravir, remdesivir, interference drug, ribavirin, arbidol and lopinavir, etc.; (except those with the wash-out time longer than 5 half-lives);

• Those who have participated in clinical trials of SARS-CoV-2 neutralizing antibodies or participated in clinical trials of other drugs within 4 weeks before screening;

• Those who have a history of severe allergies or are sensitive to inhaled allergens; or are known to be sensitive to the ingredients of the study drug, other monoclonal antibody drugs, and therapeutic protein preparations (fresh or frozen plasma, human serum albumin, cytokines, interleukin, etc.) Factors, etc.) have allergies or hypersensitivity reactions;

• Those who have received the COVID-19 vaccine within 2 weeks before the study drug administration or plan to receive the COVID-19 vaccine during the study;

• Those who cannot tolerate with nasal spray treatment;

• Any other circumstances that the researchers deemed not suitable for participating in the study.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection

Intervention

Drug:
• HH-120 Nasal Spray
HH-120 nasal spray, 1 spray to each nostril of the participant each time,8-10 times per day, until the discharge of the SARS-CoV-2 infected patients or confirmed infection of the participant, whichever occurs first.

Locations

Country	Name	City	State
China	Beijing Ditan Hospital,Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Ditan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of subjects infected with SARS-CoV-2		As of the discharge of the SARS-CoV-2 infected patients, an average 1 week
Secondary	The incidence and severity of adverse events and the serious adverse events		As of the 7th day after the last study drug administration